Clinical performance of a bone-anchored annular closure device in older adults

Gerrit J Bouma,1 Ardeshir Ardeshiri,2 Larry E Miller,3 Erik Van de Kelft,4,5 Richard Bostelmann,6 Peter D Klassen,7 Charlotte Flüh,8 Adisa Kur&scaron;umović91Department of Neurosurgery, OLVG and Amsterdam University Medical Centers, Amsterdam, the Netherlands; 2Section for Spine Surgery...

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Autores principales:	Bouma GJ, Ardeshiri A, Miller LE, Van de Kelft E, Bostelmann R, Klassen PD, Flüh C, Kuršumović A
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	annulus fibrosus disc elderly herniation lumbar sciatica Geriatrics RC952-954.6
Acceso en línea:	https://doaj.org/article/d5e44da960af4f6a9fa44d5ac2ed24df
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spelling	oai:doaj.org-article:d5e44da960af4f6a9fa44d5ac2ed24df2021-12-02T01:03:47ZClinical performance of a bone-anchored annular closure device in older adults1178-1998https://doaj.org/article/d5e44da960af4f6a9fa44d5ac2ed24df2019-06-01T00:00:00Zhttps://www.dovepress.com/clinical-performance-of-a-bone-anchored-annular-closure-device-in-olde-peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998Gerrit J Bouma,1 Ardeshir Ardeshiri,2 Larry E Miller,3 Erik Van de Kelft,4,5 Richard Bostelmann,6 Peter D Klassen,7 Charlotte Flüh,8 Adisa Kur&scaron;umović91Department of Neurosurgery, OLVG and Amsterdam University Medical Centers, Amsterdam, the Netherlands; 2Section for Spine Surgery, Klinikum Itzehoe, Itzehoe, Germany; 3Miller Scientific Consulting, Asheville, NC, USA; 4Department of Neurosurgery, AZ Nikolaas, Sint-Niklaas, Belgium; 5Antwerp University, Antwerp, Belgium; 6Department of Neurosurgery, University Clinic Düsseldorf, Duesseldorf, Germany; 7Department of Neurosurgery, St. Bonifatius Hospital, Lingen, Germany; 8Department of Neurosurgery, University Medical Center Schleswig-Holstein, Kiel, Germany; 9Department of Neurosurgery, Donauisar Klinikum Deggendorf, Deggendorf, GermanyBackground: Lumbar discectomy is a common surgical procedure in middle-aged adults. However, outcomes of lumbar discectomy among older adults are unclear.Methods: Lumbar discectomy patients with an annular defect ≥6 mm width were randomized to receive additional implantation with a bone-anchored annular closure device (ACD, n=272) or no additional implantation (controls, n=278). Over 3 years follow-up, main outcomes were symptomatic reherniation, reoperation, and the percentage of patients who achieved the minimum clinically important difference (MCID) without a reoperation for leg pain, Oswestry Disability Index (ODI), SF-36 Physical Component Summary (PCS) score, and SF-36 Mental Component Summary (MCS) score. Results were compared between older (≥60 years) and younger (<60 years) patients. We additionally analyzed data from two postmarket ACD registries to determine consistency of outcomes between the randomized trial and postmarket, real-world results.Results: Among all patients, older patients suffered from crippling or bed-bound preoperative disability more frequently than younger patients (57.9% vs 39.1%, p=0.03). Among controls, female sex, higher preoperative ODI, and current smoking status, but not age, were associated with greater risk of reherniation and reoperation. Compared to controls, the ACD group had lower risk of symptomatic reherniation (HR=0.45, p<0.001) and reoperation (HR=0.54, p=0.008), with risk reductions comparable in older vs younger patients. The percentage of patients achieving the MCID without a reoperation was higher in the ACD group for leg pain (81% vs 72%, p=0.04), ODI (82% vs 73%, p=0.03), PCS (85% vs 75%, p=0.01), and MCS (59% vs 46%, p=0.007), and this benefit was comparable in older versus younger patients. Comparable benefits in older patients were observed in the postmarket ACD registries.Conclusion: Outcomes with lumbar discectomy and additional bone-anchored ACD are superior to lumbar discectomy alone. Older patients derived similar benefits with additional bone-anchored ACD implantation as younger patients.Keywords: annulus fibrosus, disc, elderly, herniation, lumbar, sciaticaBouma GJArdeshiri AMiller LEVan de Kelft EBostelmann RKlassen PDFlüh CKuršumović ADove Medical Pressarticleannulus fibrosusdiscelderlyherniationlumbarsciaticaGeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 14, Pp 1085-1094 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	annulus fibrosus disc elderly herniation lumbar sciatica Geriatrics RC952-954.6
spellingShingle	annulus fibrosus disc elderly herniation lumbar sciatica Geriatrics RC952-954.6 Bouma GJ Ardeshiri A Miller LE Van de Kelft E Bostelmann R Klassen PD Flüh C Kuršumović A Clinical performance of a bone-anchored annular closure device in older adults
description	Gerrit J Bouma,1 Ardeshir Ardeshiri,2 Larry E Miller,3 Erik Van de Kelft,4,5 Richard Bostelmann,6 Peter D Klassen,7 Charlotte Flüh,8 Adisa Kur&scaron;umović91Department of Neurosurgery, OLVG and Amsterdam University Medical Centers, Amsterdam, the Netherlands; 2Section for Spine Surgery, Klinikum Itzehoe, Itzehoe, Germany; 3Miller Scientific Consulting, Asheville, NC, USA; 4Department of Neurosurgery, AZ Nikolaas, Sint-Niklaas, Belgium; 5Antwerp University, Antwerp, Belgium; 6Department of Neurosurgery, University Clinic Düsseldorf, Duesseldorf, Germany; 7Department of Neurosurgery, St. Bonifatius Hospital, Lingen, Germany; 8Department of Neurosurgery, University Medical Center Schleswig-Holstein, Kiel, Germany; 9Department of Neurosurgery, Donauisar Klinikum Deggendorf, Deggendorf, GermanyBackground: Lumbar discectomy is a common surgical procedure in middle-aged adults. However, outcomes of lumbar discectomy among older adults are unclear.Methods: Lumbar discectomy patients with an annular defect ≥6 mm width were randomized to receive additional implantation with a bone-anchored annular closure device (ACD, n=272) or no additional implantation (controls, n=278). Over 3 years follow-up, main outcomes were symptomatic reherniation, reoperation, and the percentage of patients who achieved the minimum clinically important difference (MCID) without a reoperation for leg pain, Oswestry Disability Index (ODI), SF-36 Physical Component Summary (PCS) score, and SF-36 Mental Component Summary (MCS) score. Results were compared between older (≥60 years) and younger (<60 years) patients. We additionally analyzed data from two postmarket ACD registries to determine consistency of outcomes between the randomized trial and postmarket, real-world results.Results: Among all patients, older patients suffered from crippling or bed-bound preoperative disability more frequently than younger patients (57.9% vs 39.1%, p=0.03). Among controls, female sex, higher preoperative ODI, and current smoking status, but not age, were associated with greater risk of reherniation and reoperation. Compared to controls, the ACD group had lower risk of symptomatic reherniation (HR=0.45, p<0.001) and reoperation (HR=0.54, p=0.008), with risk reductions comparable in older vs younger patients. The percentage of patients achieving the MCID without a reoperation was higher in the ACD group for leg pain (81% vs 72%, p=0.04), ODI (82% vs 73%, p=0.03), PCS (85% vs 75%, p=0.01), and MCS (59% vs 46%, p=0.007), and this benefit was comparable in older versus younger patients. Comparable benefits in older patients were observed in the postmarket ACD registries.Conclusion: Outcomes with lumbar discectomy and additional bone-anchored ACD are superior to lumbar discectomy alone. Older patients derived similar benefits with additional bone-anchored ACD implantation as younger patients.Keywords: annulus fibrosus, disc, elderly, herniation, lumbar, sciatica
format	article
author	Bouma GJ Ardeshiri A Miller LE Van de Kelft E Bostelmann R Klassen PD Flüh C Kuršumović A
author_facet	Bouma GJ Ardeshiri A Miller LE Van de Kelft E Bostelmann R Klassen PD Flüh C Kuršumović A
author_sort	Bouma GJ
title	Clinical performance of a bone-anchored annular closure device in older adults
title_short	Clinical performance of a bone-anchored annular closure device in older adults
title_full	Clinical performance of a bone-anchored annular closure device in older adults
title_fullStr	Clinical performance of a bone-anchored annular closure device in older adults
title_full_unstemmed	Clinical performance of a bone-anchored annular closure device in older adults
title_sort	clinical performance of a bone-anchored annular closure device in older adults
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/d5e44da960af4f6a9fa44d5ac2ed24df
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Clinical performance of a bone-anchored annular closure device in older adults

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